Viking Therapeutics, Inc. announced that it has signed a broad, multi-year manufacturing agreement with CordenPharma, an industry-leading contract development and manufacturing organization (CDMO), covering both the active pharmaceutical ingredient (API) and final finished product supply for its VK2735 program for obesity. The agreement provides Viking with sufficient long-term supply of both subcutaneous and oral VK2735 product forms to support a potential multi-billion-dollar annual product opportunity.

Under the terms of the agreement, Viking has secured dedicated capacity for the manufacture of, and a commitment to supply annually, multiple metric tons of VK2735 API.  In addition, CordenPharma will provide fill/finish capacity for both the injectable and oral formulations of VK2735. This includes dedicated manufacturing lines and an annual commitment to supply 100 million autoinjectors and an additional 100 million vial and syringe products for the subcutaneous formulation, as well as an annual capacity of over one billion oral VK2735 tablets. These API and final finished product capacities are further expandable at Viking's option. 

"We are excited to enter into this agreement with one of the world's leading CDMOs in the peptide space," said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "We have a long history of working with CordenPharma and are happy to extend and strengthen our relationship with this agreement. CordenPharma's established presence in commercial peptide manufacturing gives us confidence in their ability to deliver supply commensurate with what we anticipate will be significant commercial demand. In addition, CordenPharma's ability to provide dedicated capacity across the supply chain, from API through finished commercial products, makes them a uniquely qualified partner to work with in bringing this important therapy to the market."

In exchange for dedicated API and fill/finish capacity, Viking will make prepayments totaling $150 million, to be paid over the period from 2025 to 2028. Prepayments will be credited against future orders. Viking retains ownership of all global rights to VK2735 under the agreement and expects to maintain standard pharmaceutical product margins.

VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity. Viking is currently conducting the Phase 2 VENTURE-Oral Dosing Trial of VK2735 dosed as an oral tablet once daily for 13 weeks. Additionally, the company plans to initiate Phase 3 development with the subcutaneous formulation of VK2735 in the second quarter of 2025.